TMF Lead II (LATAM)

Key Responsibilities:

• Ensure timely review, processing, and quality of TMF documents in accordance with GCP and SOPs.
• Create and execute study TMF plans, manage document indexing, and ensure team understanding.
• Monitor TMF health, identify risks, and support audits and inspections.

Minimum Qualifications:

• Bachelor's degree or international equivalent.
• At least 3 years of related experience.
• Professional working proficiency in English.

Preferred Skills:

• Proficiency in Microsoft Office suite.
• Experience with eTMF systems and knowledge of FDA/ICH-GCP regulations.
• Strong organizational, interpersonal, and communication skills.